Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 试验地点
- 17
- 主要终点
- Overall Survival
研究概览
简要总结
Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.
详细描述
TREATMENT PLAN
6.0.1 Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Patients in this arm should not receive stereotactic doses or radiotherapy boosts.
Treatment recommendations are as follows:
Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Willing to provide informed consent
- •Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- •ECOG performance status 0-1
- •Controlled primary tumor
- •a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
- •All sites of disease can be safely treated based on criteria below
- •Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
- •Life expectancy >6 months
- •Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
- •Prior chemotherapy allowed but no systemic therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction
- •Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):
- •a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
- •a. If that previously treated metastasis is NOT controlled on imaging:
- •If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
- •If the previous treatment was radiotherapy or RFA, the patient is ineligible.
- •Patient presented at multidisciplinary tumor board or quality-assurance rounds.
排除标准
- •Serious medical comorbidities precluding radiotherapy
- •Bone metastasis in a femoral bone
- •Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
- •Prior radiotherapy to a site requiring treatment
- •Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
- •Malignant pleural effusion
- •Inability to treat all sites of active disease
- •Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on Magnetic Resonance Imaging (MRI).
- •Dominant brain metastasis requiring surgical decompression
- •Pregnant or lactating women
结局指标
主要结局
Overall Survival
时间窗: At approximately end of year 4 (study completion)
次要结局
- Quality of life: Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)(At approximately end of year 2, and end of year 4 (study completion))
- Progression-free survival(At approximately end of year 2, and end of year 4 (study completion))
- Lesional control rate(At approximately end of year 2, and end of year 4 (study completion))
- Number of cycles of further chemotherapy/systemic therapy(At approximately end of year 2, and end of year 4 (study completion))
- Toxicity: Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)(At approximately the end of years 1, 2, 3, and 4 (study completion))
研究者
David Palma
Principal Investigator
Lawson Health Research Institute